Phase 2 Seattle Dietary Biomarkers Development Center

Launched by MARIAN NEUHOUSER · Oct 22, 2024

Keywords

ClinConnect Summary

The Seattle Dietary Biomarker Development Center (S-DBDC) is conducting a study to improve how we measure what people eat. Instead of relying on people to remember and report their diets, the researchers want to find better ways to measure food intake using biomarkers—substances in the body that reflect diet. They will invite healthy adults to participate in controlled feeding studies at the Fred Hutch campus, where they will eat specific meals, and researchers will collect samples of blood, urine, and stool to study how the body processes food.

To be eligible for this study, participants must be at least 18 years old, healthy, and willing to visit the research site ten times during the study. However, certain people cannot participate, such as those who are pregnant, have specific gastrointestinal issues, or regularly consume large amounts of alcohol or tobacco. Participants can expect to be involved in a structured program where their diet is closely monitored, and they will help contribute to important research that could improve our understanding of nutrition.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Healthy adults;
• • Age 18 years or older;
• • Willing to come to the Fred Hutch campus 10 times during the study; BMI 18.5-39.9 kg/m2
• Exclusion criteria:
• • Pregnancy or lactation;
• • allergy or aversion to any of the foods that will be studied and/or provided;
• • history of gastrointestinal disorders including ulcerative colitis, Crohn's disease, celiac sprue, hereditary non-polyposis colorectal cancer (HNPCC), familial adenomatous polyposis, pancreatic disease, or liver disease;
• • previous gastrointestinal resection or bariatric surgery;
• • bleeding disorders that precludes blood draws;
• • recent hospital admissions (past 6 months) for heart disease (MI/CVA or CHF) or other CVD/CAD conditions under physician guided therapy that is not medically stable;
• • cancer under radiation or chemotherapy treatment that is active or within 6 months of treatment;
• • weight change (±5% in the last 3 months);
• • regular alcohol intake of \> 2 drinks/day (equivalent to 720 mL of beer, 240 mL of wine, or 90 mL of spirits), and unwilling to abstain during feeding periods;
• • use of tobacco and/or marijuana, hookahs, e-cigarettes (e-cigs, vapes, etc) and not willing to abstain during feeding periods;
• • use of illicit drugs and not willing to abstain during feeding periods;
• • BMI ≥40 kg/m2; regular (daily to weekly) use of over-the-counter (OTC) weight-loss aids or anti-inflammatories, and unwilling or unable to stop taking these during feeding periods;
• • unwilling to stop taking OTC dietary supplements that interfere with the test foods being studied including pills, chewables, liquids or powders for the following: protein supplements, soy, fiber, flaxseed, fish oil (including cod liver oil), probiotics, carotenoids, selenium, other antioxidants, other phytochemicals, glucosamine and chondroitin (if vitamin supplement is MD prescribed - may continue);
• • oral or IV antibiotic use in the past 6 months (could defer participation until 6 months post-completion of course of antibiotics);
• • seated blood pressure \>140/90 mmHg; fasting clinical lab tests outside acceptable values as ascertained at the screening blood draw (see Table 2 in protocol document);
• • current use of specific prescription medication(s) (see Table 3 in protocol document); and
• • inability to freely give informed consent.